Multi-layer film welded articulated balloon

ABSTRACT

A method of fabrication of a medical balloon, and a balloon device useful for various medical balloon procedures, such as gastrointestinal, vascular, reproductive system, urinary system and pulmonary applications. At least two layers of a thermoplastic film are sealed at their peripheral edges and heat sealed at one or more locations inside an area enclosed by the sealed edges at predetermined locations, in one implementation of the balloon device. Such configuration enables the balloon to articulate to a desired shape upon inflation, with the desired shape being selected to accommodate a specific medical application.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation under 35 U.S.C. §120 of U.S. patentapplication Ser. No. 13/685,448 filed Nov. 26, 2012 in the names ofTILAK M. SHAH and CHRISTOPHER D. STROM for “Multi-Layer Film WeldedArticulated Balloon,” which is a continuation under 35 U.S.C. §120 ofU.S. patent application Ser. No. 13/154,229 filed Jun. 6, 2011 in thenames of TILAK M. SHAH and CHRISTOPHER D. STROM for “Multi-Layer FilmWelded Articulated Balloon,” which is a continuation under 35 U.S.C.§120 of U.S. patent application Ser. No. 12/237,897 filed Sep. 25, 2008in the names of TILAK M. SHAH and CHRISTOPHER D. STROM for “Multi-LayerFilm Welded Articulated Balloon” and issued Jul. 12, 2011 as U.S. Pat.No. 7,976,497, which in turn claims the benefit of priority under 35U.S.C. §119 of U.S. Provisional Patent Application No. 60/974,884 filedSep. 25, 2007 in the names of TILAK M. SHAH and CHRISTOPHER D. STROM for“Multi-Layer Film Welded Articulated Balloon.” The disclosures of eachof the foregoing U.S. patent application Ser. No. 13/154,229, U.S. Pat.No. 7,976,497 and U.S. Provisional Patent Application No. 60/974,884 arehereby incorporated herein by reference, in their respective entiretiesfor all purposes.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to low pressure medical balloon articlesand to the methodology for making the same, and in particular to amedical balloon useful for in vivo luminal medical procedures.

2. Description of the Prior Art

Various balloon articles are in use for cardiovascular and other medicalprocedures (such as percutaneous transluminal angioplasty, percutaneoustransluminal nephrostomy, urethral dilatation, biliary duct dilatation,percutaneous transluminal renal angioplasty, and the like). Balloons maybe utilized for such procedures, that are inflatable or otherwisecapable of holding pressure. Pressure levels of balloons may be widelyvaried, depending on the specific application, and may for example be ina range of from 30-150 pounds per square inch (psi) for higher pressuresand balloons and 1-10 psi for low pressure balloons.

Low pressure balloons are there which can hold a pressure on the orderof 1-3 psi. Low pressure balloons are typically used forgastrointestinal applications. In other applications, balloons areemployed in cardiovascular applications for blocking blood flow, or forremoving/blocking a blood clot. In such applications, the balloon istypically bonded to the shaft of a catheter, and after inflation anduse, the balloon is readily retracted to an original catheter sleeveshape.

An issue confronting the use of balloon articles for in vivo usage isthe asymmetric character of the inflation.

There have been various attempts to shape the balloon so it can bearticulated after inflation in vivo for its intended use. For example,in angioplasty applications, clots found in arteries should be heldagainst the artery walls until treated or removed. In prostatetreatments it is often desirable to space the prostate from the rectumwhile treating the same with radiation.

Usually, to achieve the desired inflated shape in low pressure balloons,the balloon material, often latex, is prestretched so as to achieve thedesired final shape or the balloon has discrete portions which areoverinflated so as to assume a desired shape after insertion andinflation. Another tactic employed is to precure particular selectedballoon material so that when inflated, the balloon will assume theprecured shape, or to form the balloon with a wall thickness which mayvary at different locations in the balloon so as to expand at differentrates to achieve different shaped portions in the balloon.

While the resultant balloon would be operational for its intendedpurpose, each requires an involved fabrication methodology.

SUMMARY OF THE INVENTION

The present invention relates to balloon articles useful in variousmedical procedures.

In one aspect, the present invention provides a method of fabrication ofa medical balloon which uses at least two layers of a thermoplastic filmsealed at their edges or periphery and heat sealed at one or morelocations inside the area enclosed by the sealed edge at preselectedlocations, which enables the balloon to articulate to a desired shapeupon inflation, with the specific shape being dependent on theparticular medical application. The layers may have a differentthickness or modulus of elasticity or any combination thereof or thesame thickness and modulus, and different dimensioned channels formed bythe heat sealed locations to articulate to a desired shape.

In a specific aspect, the invention relates to a method for thefabrication of an articulated medical balloon device comprising thesteps of:

-   -   (a) providing at least two film layers having opposed edges;    -   (b) sealing said opposed edges to form a compartment adapted to        receive fluid to expand said film layers relative to each other;    -   (c) providing an opening in said fluid compartment that is        adapted to receive a lumen; and    -   (d) forming a subcompartment between the sealed edges of said        compartment of a predetermined shape and dimension by sealing at        least one of said layers to another, intermediate said opposed        edges.

In a further aspect, the invention relates to a medical balloon device,comprising:

-   -   at least one film layer having an edge secured to a second film        layer to form a fluid compartment therebetween,    -   and portions of said film layers between said edges being        secured intermediate said edges to form a plurality of        subcompartments, and    -   said fluid compartment being provided with an opening to receive        a lumen.

Additional aspects, features and embodiments will be more fully apparentfrom the ensuing disclosure and appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top plan view of one embodiment of the balloon of thepresent invention.

FIG. 2 is a cross-sectional view of the balloon of FIG. 1 takensubstantially along the plane indicated by the line 2-2 of FIG. 1.

FIG. 3 is a top plan view of a second embodiment of the balloon of thepresent invention.

FIG. 4 is a cross-sectional view of the balloon of FIG. 3 takensubstantially along the plane indicated by the line 4-4 of FIG. 3.

FIG. 5 is a perspective view of the articulated balloon of FIG. 3 afterinflation.

FIG. 6 is a top plan view of yet another embodiment of the balloon ofthe present invention.

FIG. 7 is a cross-sectional view of the balloon of FIG. 6 takensubstantially along the plane indicated by line 7-7 of FIG. 6.

FIG. 8 is a perspective view of still another embodiment of anarticulated balloon according to the present invention.

FIG. 9 is a cross-sectional view of the balloon of FIG. 8 takensubstantially along the plane indicated by line 9-9 of FIG. 8.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now to the drawings in detail, wherein like numerals indicatelike elements throughout the several views, each of the inflatableballoon structures of the present invention, e.g., the balloon structure10 of FIG. 1, comprises a multilayer arrangement of film layers 12, 14or more, that includes an inflatable compartment 16 defining an enclosedinterior volume and an anti-reflux valve 18 positioned in a lumen orfluid passage 20 whose distal end 22 is sealingly connected to theinterior volume of compartment 16. An inflation bulb 24 is connected tothe proximal end 24 of lumen 20 upstream from the anti-reflux valve 18.The valve 18 may be a one-way check valve or a rotatable stem in ahousing having an opening adapted to be rotated into alignment with thebore of the lumen 20.

Oppositely facing film layers 26, 28 are bonded to one another alongtheir edges 30-31, 32 and 34 to form the inflatable compartment 16 andthe compartment 16 is divided into subcompartments 36 by tack or spotwelds 38 so that the subcompartments 36 are virtually square-shaped inplan so that upon inflation, the balloon compartment 16 will resemble atufted cushion with the tack or spot welds 38 forming raisedsquare-shaped subcompartments. This device can be used to separate twoorgans in the body in vivo and support the same in spaced relation.

The inflatable balloon compartment and subcompartments can be readilyformed by heat-sealing or other joining techniques commonly known andused in the art for forming structural articles from thermoplastic filmmaterials in the form of web or sheet stock. For example, RF welding,heat impulse welding, solvent welding, adhesive bonding and the like canbe employed.

Referring to the embodiment of the invention illustrated in FIGS. 3 to5, inclusive, the film layers 26′ and 28′ may be bonded to each other inthe shape of a parallelogram, with subcompartments 36′ extending inspaced relation to each other, but parallel to the side edges 30′ and34′ and at an angle to the opposite edges 31′ and 32′ by tack or spotwelds 38′. As shown in FIG. 5, upon inflation, the fluid forceintroduced into the subcompartments 36′ will cause the balloon device10′ to curl into a spiral about a longitudinal axis 40.

Referring to FIGS. 6 and 7, the balloon device 10″ can be formed withrectangular subcompartments 36″ utilizing line welds 42, parallel toedges 30″ and 32″.

As shown in the embodiment illustrated in FIGS. 8 and 9, the balloondevice 100 has thermoplastic film layers 102 and 104 having differentproperties joined along their edges 106, 108, 110, and 112. For example,the materials can have a different modulus of elasticity, meaning thatthey will stretch under pressure at different rates to form a particulararcuate or curved shape. In this embodiment, the lumen 114 can extendinto the interior of the compartment 116 formed by the film layers 102and 104 and sealed to the balloon at neck 118.

Additionally, a third layer or strip of film 120 can be added or joinedto the top layer 102 to increase its thickness. This will cause thesides 108, 112 to be drawn inwardly relative to the lumen axis, uponinflation, while the distal or forward portion of the compartment 122will bulge upwardly. Such a device is useful in prostate surgery tosupport the prostate in spaced relation to other organs.

It will therefore be appreciated that the medical balloon device of theinvention may be widely varied in construction and features. In oneembodiment, the balloon device includes at least one neck member in asealing area of the device. The device in a further embodiment comprisesat least one area outside of the secured edges forming an inflationport.

While the invention has been illustratively shown and described withrespective to particular embodiments, it will be appreciated that theapplication is not thus limited, but rather extends to and encompassesother variations, modifications and additional embodiments as will beapparent to those of ordinary skill in the art, based on the disclosureherein. Accordingly, the invention is intended to be broadly construedwith respect to the ensuing claims, as encompassing all such additionalvariations, modifications and alternative embodiments.

1.-9. (canceled)
 10. A method for the fabrication of a medical balloondevice, said method comprising: providing a multiplicity of layers ofthermoplastic film having peripheral edges; sealing the peripheral edgesto form an inflatable interior volume enclosed by the sealed edges sothat the inflatable interior volume is sealed by a single seal; andsealing at least one of the layers directly to another of the layers atone or more locations in the interior volume to enable the device toarticulate to a predetermined shape upon inflation of the interiorvolume with an inflation fluid, to accommodate a predetermined medicalapplication.
 11. The method of claim 10, wherein said sealing isperformed by welding one layer to another.
 12. The method of claim 10,wherein said sealing is performed by RF welding one layer to another.13. The method of claim 10, wherein two layers of thermoplastic film areprovided.
 14. The method of claim 10, wherein three layers ofthermoplastic film are provided.
 15. The method of claim 10, whereinsaid multiplicity of layers comprise layers of different modulus ofelasticity.
 16. The method of claim 10, wherein said multiplicity oflayers comprise layers of different thickness.
 17. The method of claim10, wherein said multiplicity of layers comprise layers of thermoplasticpolymeric film.
 18. The method of claim 10, further comprisingconnecting a fluid passage to the interior volume.
 19. The method ofclaim 18, wherein the fluid passage contains a valve.
 20. The method ofclaim 19, wherein said valve comprises a check valve.
 21. The method ofclaim 19, wherein said valve comprises a rotatable stem valve.
 22. Themethod of claim 19, wherein said valve comprises an anti-reflux valve.23. The method of claim 10, wherein the predetermined shape uponinflation of the interior volume with an inflation fluid supports aprostate in spaced relation to other organs, in prostate surgery as saidpredetermined medical application.
 24. The method of claim 10, whereinthe predetermined shape includes a distal bulging shape upon inflationof the interior volume with an inflation fluid for said predeterminedmedical application.
 25. The method of claim 10, wherein thepredetermined shape upon inflation of the interior volume with aninflation fluid for said predetermined medical application, configuresthe medical balloon device for a gastrointestinal, vascular,reproductive system, urinary system, or pulmonary procedure.